The lot no for the device was provided, therefore a lot history review was performed.The device was returned for evaluation.Therefore, the investigation is confirmed for the reported inflation and material rupture.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
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H10: for the reported malfunctions, reportability was reassessed and determined to be no longer reportable.H10: the lot no for the device was provided, therefore a lot history review was performed.The device was returned for evaluation.Therefore, the investigation is confirmed for the reported inflation and material rupture.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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